SOOM MOUTHWASH- sodium fluoride, allantoin liquid
TECOZYME INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sodium Fluoride, allantoin

■ Help teeth whitening and reduce of bad breath

■ Aids in the prevention of gingivitis, periodontitis

Keep out of reach of children

Adults and children 6 years of age and older

■ Vigorously swish 11 mL between teeth twice a day for 30 seconds then spit out.

■ Do not swallow

■ Children under 6 years of age: do not use

Do not use in Children under 6 years of age

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Water, Erythritol, Xylitol, Sodium Benzoate, Glycerin, Propylene Glycol, PEG-40 Hydrogenated Caster Oil, L-Menthol, Zinc Gluconate, Sodium Citrate, Fragrance

For dental use only

label

SOOM MOUTHWASH
sodium fluoride, allantoin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79717-0001
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)
ALLANTOIN (UNII: 344S277G0Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:79717-0001-1	11 mL in 1 POUCH; Type 0: Not a Combination Product	07/24/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	07/24/2020

Labeler - TECOZYME INC (694613703)

Registrant - TECOZYME INC (694613703)

Name	Address	ID/FEI	Business Operations
Establishment
TECOZYME INC		694613703	manufacture(79717-0001)